REGULATIONS GOVERNING OPERATION AND CONDUCT OF TATTOO AND BODY PIERCING ESTABLISHMENTS

Transcription

1 CITY OF PHILADELPHIA DEPARTMENT OF PUBLIC HEALTH REGULATIONS GOVERNING OPERATION AND CONDUCT OF TATTOO AND BODY PIERCING ESTABLISHMENTS Approved: BOARD OF HEALTH....August 14, 2001 and January 23, 2002 LAW DEPARTMENT... November 21, 2001 RECORDS DEPARTMENT... February 26, 2002

2 TABLE OF CONTENTS 1.Definitions Certificates Establishment Operator Apprentice Temporary Establishment/Operator Certificates Criteria for Operating a Facility Facility Requirements Health, Cleanliness and Personal Hygiene of Operators Practices and Procedures for Tattoo Establishments Practices and Procedures for Body Piercing Notifications Temporary Establishment Requirements Exemptions Severability Administrative Compliance Provisions

3 1 1. DEFINITIONS (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l) Body Art. The practice of physical body adornment by permitted establishments and operators utilizing, but not limited to, the following techniques: body piercing, tattooing, cosmetic tattooing, branding and scarification, and the placement of pigments, trimming, or filing of the nails. Body Piercing. The process of penetrating the skin or mucous membrane for the purpose of insertion of any object, including but not limited to jewelry for cosmetic purposes. The term also includes the intentional production of scars upon the body. Body Piercing Establishment. Any room or space where body piercing is practiced or where the business of body piercing is conducted or any part thereof. Body Piercing Artist/Operator. Any person who actually performs the work of body piercing. Department. The Department of Public Health of the City, the Commissioner of the said Department, or any authorized representative thereof. Disinfection. The destruction of all vegetative forms of pathogenic agents by chemical or physical means. Equipment. All machinery, including fixtures, containers, vessels, tools, implements, furniture, display and storage areas, sinks, and other apparatus used in connection with the operation of any establishment. Establishment. Any place or premise, whether public or private, where any person conducts any enterprise, occupation, vocation or business, whether or not for profit and whether temporarily or permanently located. Facility Manager. Any person who controls, operates, conducts or manages any tattooing or body piercing establishment, whether actually performing tattooing or body piercing or not. Hot Water. Water which is at a temperature of not less than 110ºF nor greater than 125ºF. Infection. The entry and multiplication of any pathogen in the body of a human or animal. Infectious Disease. A disease of humans or animals resulting from a

4 2 (m) (n) (o) (p) (q) (r) (s) (t) (u) transmissible infection, whether or not patent, apparent, inapparent, latent, clinical or subclinical. Infectious Waste. Waste generated in the treatment or service of a human which falls under one or more of the following categories: (1) Pathological wastes. Human pathological wastes, including tissues that are removed during medical procedures. The term does not include hair, nails or extracted teeth. (2) Human blood and body fluid waste including liquid waste, human blood, blood products, items contaminated with blood or dried human blood. (3) Used Sharps. Needles, scalpel blades, suture needles, broken or unbroken glass or plasticware, disposable razors, scalpel blades, and other sharp objects that have cut or pierced the skin or have been in contact with infectious agents. Municipal Waste. Garbage, refuse, industrial lunchroom or office waste and other material, including solid, liquid, semisolid or contained gaseous material resulting from operation of residential, municipal, commercial or institutional establishments and from community activities. Sanitization. The reduction of the population of microorganisms to safe levels as determined by public health officials. Sterilization. Process of destruction of all forms of life by physical or chemical means. Tattoo. The indelible mark, figure or decorative design introduced by insertion of nontoxic dyes or pigments into or under the subcutaneous portion of the skin of a human being. Tattooing. The process by which the skin is marked or colored by insertion of nontoxic dyes or pigments into or under the subcutaneous portion of the skin so as to form indelible marks for cosmetic, medical or figurative purposes. Tattoo Artist/Operator. Any person who actually performs the work of tattooing. Tattoo Establishment. Any room or space where tattooing is practiced or where the business of tattooing is conducted or any part thereof. Temporary Tattoo/Body Piercing Establishment. A tattoo/body piercing establishment that operates at a fixed location for a period of time of not more than seven (7) consecutive days in conjunction with

5 2. CERTIFICATES a single event or celebration. 3 A. ESTABLISHMENT CERTIFICATE (1) No person, firm, partnership, joint venture, association, business trust, corporation or any organized group of persons may operate a tattooing or body piercing establishment unless it has received a tattooing/body piercing establishment certificate from the Department. (2) Any person operating a tattooing/body piercing establishment shall obtain a certificate from the Department annually. (3) The applicant shall pay a fee of one hundred (100) dollars for each tattooing/body piercing establishment certificate. (4) A certificate for a tattooing/body piercing establishment shall not be transferable from one place or person to another. (5) A certificate shall automatically expire on December 31st of each year unless renewed by the Department upon the request of the licensee and payment of the fee. (6) A current tattooing/body piercing establishment certificate shall be posted in a prominent and conspicuous area where it may be readily observed by patrons. B. OPERATOR CERTIFICATE (1) No person shall practice the art of tattooing or body piercing within the City of Philadelphia without first obtaining a certificate from the Department. (2) All certificates shall be valid from the date of issuance and shall automatically expire in three years from the date of issuance unless revoked sooner by the Department. (3) No certificate to practice the art of tattooing or body piercing shall be issued unless: (a) the applicant furnishes proof of having previously held such a certificate, OR (b) the applicant furnishes proof of having served an apprenticeship in tattooing under an operator's certificate pursuant to this Section for a period of at least three (3) years, or apprenticeship in body piercing under an

6 4 operator s certificate pursuant to this Section for a period of at least eighteen (18) months, OR (c) the applicant furnishes proof of having practiced the art of tattooing or body piercing as a full-time occupation prior to the date of the passage of these regulations; AND (d) the applicant furnishes proof of having attended a bloodborne pathogens training program given or approved by the Department within the past three (3) years; AND (e) (f) the applicant pays the forty (40) dollar certificate fee. Upon adoption of these regulations, individuals who comply with all of the above provisions except (d) relating to bloodborne pathogens training will be issued a temporary certificate valid for a period of six months. At the end of this period, upon proof of attendance, a permanent certificate (valid for three years ) will be issued. (4) Each application for a certificate shall set forth: (a) the name and address of the applicant; (b) a physical description of the premises where tattooing/body piercing is to be done; (c) such other information as the Department may require. (5) No certificate shall be issued unless, following reasonable investigation by the Department, the tattoo/body piercing operator has demonstrated compliance with the provisions of this Section and all applicable provisions of Title 6, the Health Code. (6) All certificates shall be conditioned upon continued compliance with the provisions of this Section as well as all applicable provisions of Title 6, the Health Code. (7) The certificate shall be posted in a prominent and conspicuous area where it may be readily observed by patrons. C. APPRENTICE CERTIFICATE (1) Any person certified as a tattoo/body piercing operator pursuant to this Section may apply to the Department for one or more apprentice certificates which, upon issuance, will allow the apprentice named thereon to practice tattooing in the

7 5 establishment of and under the direct supervision of the certified operator named thereon, for a period of three (3) years or practice body piercing in the establishment of and under the direct supervision of the certified operator named thereon, for a period of eighteen (18) months. (2) The applicant pays the forty (40) dollar certificate fee. (3) The apprentice certificate shall be posted in a prominent and conspicuous area where it may be readily observed by patrons. D. TEMPORARY ESTABLISHMENT/OPERATOR CERTIFICATE Temporary establishment and, when required, operator certificates may be issued for tattooing/body piercing services provided outside of the physical site of a certified facility for the purposes of product demonstration, industry trade shows or for educational reasons. The provision of tattooing/body piercing services at a mobile facility without a temporary establishment certificate issued in accordance with this section is prohibited. (1) Temporary operator and/or establishment certificates will not be issued unless: (a) the applicant furnishes proof of compliance with section B relating to operator certificates; and (b) the applicant is currently affiliated with a fixed permanent facility which, where applicable, is licensed by the appropriate State and/or local jurisdiction; and (c) the temporary site complies with section 9, Temporary Establishment Requirements, of this regulation. (2) In lieu of attendance at a bloodborne pathogens training program given by the Department within the past three (3) years as specified in section (2) (d) above, the applicant may furnish proof of attendance at equivalent training which is acceptable to the Department. (3) Temporary certificates expire after seven days or the conclusion of the special event, whichever is less. (4) Temporary operator and/or establishment certificate(s) will not be issued unless the applicant has paid a reasonable fee as set by the Department. (5) The temporary establishment/operator certificate(s) shall not be transferable from one place or person to another.

8 6 (6) The temporary establishment/operator certificates shall be posted in a prominent and conspicuous area where they may be readily observed by patrons. 3. CRITERIA FOR OPERATING A FACILITY A. Each facility manager shall: (1) Require each individual working within the facility premises providing tattooing/body piercing services to have a valid tattoo/body piercing operator or apprentice certification. (2) Be responsible for maintaining a list of certified operators or apprentices employed at the facility for review by the Department upon request. (3) Post the valid establishment, operator(s), or apprentice certificates. (4) Comply with all the requirements of this regulation. (5) Allow the Department representative to inspect the facility when it is open for business. (6) Notify the Department in writing by mail or in person within 5 calendar days of closure of the facility. If the same owner reopens the facility while the license is still current, the facility operator is to inform the Department prior to resuming business. B. Tattooing/body piercing services shall not be provided outside of a certified establishment unless a temporary establishment certificate has been obtained pursuant to section 2 of this regulation. C. The facility shall comply with the most current version of the U.S. Department of Labor, Occupational Safety and Health Administration (OSHA) Occupational Exposure to Bloodborne Pathogens Standard, 29 CFR , including OSHA instruction CPL C, or later editions. 4. FACILITY REQUIREMENTS A. LOCATION All tattoo/body piercing establishments shall be completely separated by solid partitions, or by walls extending from floor to ceiling, from

9 7 any room used for human habitation, a food establishment or room where food is prepared, a hair salon, retail sales, or other such activity which may cause potential contamination of work surfaces. If such partition or wall contains a door or window, the door shall be selfclosing and kept closed and the window shall not be able to be opened. When partitions are authorized to be used to separate areas within the establishment, such partitions shall not extend closer than eighteen (18) inches to the ceiling, and shall permit free circulation of air. B. FLOORS Floors shall be constructed of approved materials so as to be durable, easily cleanable, and free of open holes or cracks and shall be kept clean and in good repair. Carpeting or other porous floor coverings are not permitted in the service areas of the establishment. The juncture between the floor and the wall shall be closed, and in new establishments or those extensively altered, it shall also be coved to permit effective cleaning. Floors shall be kept clean by dustless methods. C. WALLS, CEILINGS, PARTITIONS, FIXTURES, EQUIPMENT AND OTHER APPURTENANCES (1) Walls and partitions in service areas shall be easily cleanable and kept in good repair. Walls, partitions, ceilings, cabinets, shelves, drawers, furniture, fixtures, and all other equipment and appurtenances shall be easily cleanable and kept clean and finished in a color that will not conceal the presence of soil. (2) Furniture used by the client during procedures is to be of nonporous materials and cleaned after each. Work tables shall be constructed of smooth easily cleanable material and cleaned between each use. A properly designed and installed equipment washing sink adequate for the needs of the establishment is to be located convenient to the work area. D. LIGHTING General illumination of at least ten (10) foot-candles at a point thirty (30) inches above the floor level shall be provided in all rooms, and illumination of at least one hundred (100) foot-candles shall be provided at all working surfaces where services are provided to patrons and where tools and instruments are cleaned and sanitized or

10 8 sterilized. Such illumination shall be reasonably free from glare and distributed so as to avoid shadows. E. VENTILATION Ventilation shall be provided so as to prevent condensate and excess moisture and to remove objectionable odors and toxic substances. Construction and operation of ventilation facilities shall be such as to prevent undue chill. Exhaust outlets shall be constructed and operated so as to avoid creating a nuisance to adjacent areas as prescribed by the Air Pollution Code (Title 3 of the Code of General Ordinances, and regulations adopted thereunder) of the City of Philadelphia. F. WATER SUPPLY Water shall be of a safe, sanitary quality from a source approved by the Department and shall be provided in adequate quantity and pressure in all rooms used for service of patrons and/or cleaning of tools and instruments. All hand washing facilities, containers, and sinks used for cleaning of tools and instruments or hand washing shall be provided with cold and hot water conveniently available at all times when the establishment is open for service. G. LIQUID WASTE DISPOSAL All liquid wastes shall be disposed in accordance with the requirements of the Plumbing and Health Codes and regulations adopted thereunder, and any other applicable ordinances and regulations of the City of Philadelphia. Such wastes shall be discharged into the municipal sewerage system, if available. If such system is not available, liquid wastes shall be disposed of in a manner approved by the Department. H. REFUSE STORAGE AND DISPOSAL (1) Hair particles, paper, tissues, cottons, and other waste materials shall be kept stored in tightly covered waste containers. Refuse containers in areas where services are provided to patrons shall be emptied and cleaned at least daily. All refuse containers shall be cleanable and kept clean. All waste materials are to be removed from the premises at least weekly. Used bandages, gauze or other disposable items which are contaminated with blood or dried blood are to be placed in closable, leak-proof color-coded or labeled containers built to contain all contents during handling, storing, transporting, or

11 9 shipping. These containers are to be sterilized in an autoclave prior to disposal or transported and processed by an infectious waste transporter and disposal site approved by the PA Department of Environmental Protection. Where on-site autoclaving is utilized, autoclavable plastic bags are to be used for containerization of the waste. (2) Needles or any other sharp objects which may have come into contact with blood or blood products are to be placed in a closable, puncture-resistant, disposable container which is leakproof on the sides and bottom and labeled or color coded to identify the contents as a biohazard. These containers are to be sterilized in an autoclave prior to disposal or transported and processed by an infectious waste transporter and disposal site approved by the PA Department of Environmental Protection. I. SANITARY FACILITIES Toilet and lavatory facilities shall be adequate, conveniently located and available during working hours for all persons working in the establishment, and shall comply with applicable statutes, ordinances and regulations. Toilet rooms shall be constructed with smooth, washable floors, walls and ceilings and shall be kept clean, well illuminated and in good repair and finished in a color so as not to conceal the presence of soil. Toilet rooms shall be ventilated to the outside air as prescribed in the Plumbing Code, and discharge vents shall conform to the requirements of the Air Pollution Code and regulations adopted thereunder. A handwash sink with hot and cold running water shall be located in the work area and shall be for the exclusive use of the tattoo artist/body piercer for handwashing and preparing the customer. The sink shall be equipped with wrist or foot operated controls, approved germicidal soap solution provided by means of a pump dispenser, and individual disposable or autoclavable hand brushes and fingernail files for each operator. C-fold paper or other approved individual hand wiping towels are to be available. Common towels and common drinking cups are prohibited. Durable, legible signs shall be posted conspicuously in each toilet room directing employees to wash their hands before returning to work. J. INSECT, RODENT AND ANIMAL CONTROL

12 10 Effective measures shall be taken to protect against the entrance into the establishment and the breeding or presence on the premises of insects and rodents. Insects and rodents shall not be present in any part of the establishment. No live animals shall be kept or allowed in any room where tattooing or body piercing is conducted except that guide dogs accompanying physically disabled persons may be permitted. K. SOILED UTILITY AREA An area located away from work stations or areas frequented by the public is to be provided for the cleaning and/or sterilization of equipment. A sink with hot and cold running water and adequate lighting and ventilation is to be provided. 5. HEALTH, CLEANLINESS AND PERSONAL HYGIENE OF OPERATORS A. EMPLOYEE HEALTH (1) No person affected with any boils, infected wounds, open sores, acute respiratory infection or other communicable disease or condition, nausea, vomiting, diarrhea shall work in any area of a tattoo or body piercing establishment in any capacity in which there is a likelihood of contaminating tattoo or body piercing equipment, supplies or work surfaces with pathogenic organisms. (2) Proof shall be provided upon request of the Department that all operators have either completed or were offered and declined the Hepatitis B Vaccination series, antibody testing has revealed that the employee is immune to Hepatitis B, or that the vaccine is contraindicated for medical reasons. Contraindication is to be supported by a dated and signed physician s statement specifying the name of the employee and that the vaccine cannot be given. B. CLEANLINESS AND PERSONAL HYGIENE (1) Prior to starting each tattoo, piercing or handling the supplies for the procedure, the operator is to wash their hands, forearms and nails thoroughly with an antiseptic liquid soap or its

13 11 equivalent, nail brush and water. The operator's hands and forearms shall be dried with individual, single-use towels. Disposable single service surgical gloves shall be worn for any procedure involving contact with a customer s skin, hair, or other body tissue. If the operator is allergic to latex, they should use powderless or hypoallergenic gloves. Gloves shall be changed after contacting overhead lights, power supplies, telephones, ink bottles, furniture, curtains, or other nonprotected surfaces during the procedure or whenever necessary to prevent cross-contamination. Protective gloves shall be disposed of and hands shall be thoroughly washed after the procedure has been completed. (2) Every tattoo or body piercing operator shall wash their hands thoroughly with warm water and soap and use an individual clean towel after use of the toilet. (3) Each operator shall keep their outer garments clean at all times during business hours and shall be clean in person. (4) All operators shall refrain from smoking, eating or drinking in the service area. 6. PRACTICES AND PROCEDURES FOR TATTOO ESTABLISHMENTS A. INSTRUMENT CLEANING, STERILIZATION, STORAGE, HANDLING AND CONSTRUCTION (1) Cleaning and preparation of instruments for sterilization After each tattooing operation, the tubes and needle bars shall be placed in an ultrasonic-type machine to remove any foreign material. A high quality detergent material which shall be changed daily and is suitable for an ultrasonic machine is to be used. Ultrasonic cleaners must be operated with the lid on to prevent contamination of adjacent surfaces. When this process is completed, the tubes and needle bars are to be rinsed in accordance with the manufacturers directions and shall be placed in a self-sealing autoclavable bag which is dated with an expiration date not to exceed six (6) months, and sealed in preparation for autoclaving. (2) Sterilization

14 12 Each tattoo establishment is to be equipped with an autoclave which is a design, style or model that has received clearance by the U. S. Food and Drug Administration for conformance with section 510 (k) of the Federal Food, Drug and Cosmetic Act. Alternate sterilizing equipment may only be used when specifically approved in writing by the Department. After each use and before use on another customer, all needle bars, grips and tubes and needles shall be processed by the following procedure: cleaned, packaged in a self-sealing autoclave bag which is dated with an expiration date not to exceed six (6) months, and arranged in an autoclave which is operated in strict accordance with the manufacturer s recommendations. As the operation time of the autoclave may vary with the type of instrument, the packaging of that item and the arrangement of items in the autoclave, it is critical that the manufacturer s operation manual be followed. This will assure that each item placed in the autoclave achieves the proper temperature for sterilization. Temperature sensitive autoclave tape, autoclave bags with a chemical color indicator on the bag or any other temperature sensitive medium approved for autoclaves by the Department must be applied to each load every time the autoclave is used. To further confirm that the autoclave is operated in a manner to assure sterility of the processed instruments, it must be tested monthly using a biological indicator such as spore strips or spore suspensions which are processed by a laboratory. Records documenting such testing must be maintained by the operator for three years. A copy of the manufacturer s recommended procedures for the operation of the autoclave is to be available for inspection by the Department. (3) Storage Sterile instruments must be stored in a condition so as to maintain their sterility. All sterile and ready to use needles and instruments in their autoclaved bag or container, or in the manufacturer's original packaging shall be kept in an easily cleanable, dry enclosed glass, plastic or metal case, cabinet or drawer while not in use. Such enclosure shall be maintained in a

15 13 sanitary manner at all times. Sterile instruments may not be used if the package has been breached or after the expiration date without first repackaging and resterilizing. (4) Handling The needles and instruments shall be used, handled, and temporarily placed during tattooing so that they are not contaminated. (5) Construction Solder used for the attachment of needles to the needle bars for use in a tattoo machine shall be lead free. (6) Cleaning of Other Instruments and Articles Articles that do not penetrate the skin, but are used on customers, including containers used for the storage of items and the collection of dirty instruments, must be thoroughly cleaned before and after each use. These are to be cleaned by rinsing in warm water, thoroughly washing with hot water and soap or detergent, rinsing in water at a temperature of 160 ºF, allowed to air dry and stored in a clean, enclosed container or manner to prevent recontamination. Instruments which can be damaged by water, such as the electrical handpiece, are to be thoroughly wiped with clean cotton wool or a cotton pad saturated with 70% isopropyl alcohol, allowed to air dry and stored in a clean, enclosed container or manner to prevent recontamination. B. APPLICATION AND USE OF SINGLE USE HECTOGRAPHIC STENCILS (1) Stencils shall be single use disposable carbon or thermal spirit master units. (2) Petroleum based jellies, soaps and other products used for the application of stencils shall be dispensed and applied on the area to be tattooed with sterile gauze or in a manner to prevent contamination of the original container and its contents. If used, the gauze shall be used only once and then discarded. C. USE OF DYES, INKS AND PIGMENTS (1) All dyes, inks and pigments shall be from a source of supply which complies with applicable U. S. Food and Drug Administration regulations when available. Dyes, inks and

16 14 pigments are to be used in accordance with the manufacturer s directions and are not to be adulterated with any substance not recommended by the manufacturer. (2) Immediately before applying a tattoo, the quantity of dye, ink or pigment to be used for the tattoo shall be transferred from the supply bottles and placed into sterile, single-use paper cups or plastic caps. Upon completion of the tattoo, these single use cups or caps and their contents shall be discarded. (3) Excess dye, ink or pigment shall be removed from the skin with a single service wiping tissue or sterile gauze which shall be discarded after use on each customer. Enough wipes to be used on one customer should be kept in the working area and any not used should be immediately discarded. D. INSPECTION, SHAVING AND PREPARATION OF THE SKIN (1) No tattooing shall be done on skin surfaces which have any rash, pimples, boils, infections or any other evidence of an unhealthy condition. No tattoo operator shall remove any tattoo marks. (2) If the skin is to be shaved, it must first be washed with soap and warm water. Safety razors with single service blades for each patron shall be used for preparation of the areas to be tattooed. The blade shall be discarded after each use and the blade holder, if reused, shall be autoclaved after each use. (3) After shaving, the area to be tattooed shall be prepared by washing with soap and warm water and gently scrubbed with a sterile gauze pad soaked in a germicidal preparation that is registered with the Environmental Protection Agency. (4) The use of styptic pencils, alum blocks or other solid styptic to check the flow of blood is prohibited. E. CONCLUDING PROCEDURE After completing work on any person, the tattooed area shall be washed with a sterile gauze saturated with an approved antiseptic solution or a 70% alcohol solution. The tattooed area shall be allowed to air dry and an antibacterial cream or lotion from a single-use dispenser is to be applied using sterile gauze. A dressing shall then be affixed over the tattooed area using either a non-stick bandage (telfa) or a sterile gauze attached with adhesive tape. Where adhesive tape is

17 15 used, the client is to be advised as to the procedure for its removal. F. LINENS If reusable cloth items are used in the care and treatment of the client, they shall be changed after each use. The used linens shall be placed in a closed or covered container and laundered on a weekly basis or more frequently depending upon storage capacity and degree of contamination of the linen. Used linens shall be laundered either by a commercial laundering or by a noncommercial laundering process which includes immersion in laundry detergent and chlorine bleach water or immersion in water at 160 degrees Fahrenheit for not less than 15 minutes during the washing and rinsing operation. The laundered linens shall be stored in a clean, enclosed storage area until needed for immediate use. 7. PRACTICES AND PROCEDURES FOR BODY PIERCING A. CLEANING, STERILIZATION AND HANDLING OF INSTRUMENTS AND SUPPLIES (1) Cleaning and preparation of instruments for sterilization After each body piercing operation, insertion tapers, Pennington and other tissue forceps, nostric tubes, needle receiving tubes, ring expanding and closing pliers, files, and other instruments are to be placed in an ultrasonic type machine to remove any foreign material. A high quality detergent material which shall be changed daily and is suitable for an ultrasonic machine is to be used. Ultrasonic cleaners must be operated with the lid on to prevent contamination of adjacent surfaces. When this process is completed, the instruments to be rinsed in accordance with the manufacturers directions and placed in individual autoclavable bags or containers, dated with an expiration date not to exceed six (6) months, and sealed. (2) Sterilization of instruments or supplies At least one autoclave shall be provided for each body piercing establishment which utilizes reusable equipment or supplies requiring sterilization. Autoclaves must be of a design, style or model that has been cleared by the U. S. Food and Drug Administration for conformance with section 510 (k) of the

18 16 Federal Food, Drug and Cosmetic Act. Alternate sterilizing equipment may only be used when specifically approved in writing by the Department. After each use and before using on another customer, all clamps, pliers or equipment shall be sterilized using the following procedure: the item is to be cleaned, packaged in a peel-pack which is dated with an expiration date not to exceed six (6) months, and arranged in an autoclave which is operated in strict accordance with the manufacturer s recommendations. As the operation time of the autoclave may vary with the type of instrument, the packaging of that item and the arrangement of items in the autoclave, it is critical that the manufacturer s operation manual be followed. This will assure that each item placed in the autoclave achieves the proper temperature for sterilization. a. All new corks, rubber bands, hair clips, wooden-handled cotton swabs, toothpicks, gauze pads and other single use items are also to be autoclaved prior to use if they are not received in a sterilized condition from the manufacturer or supplier in accordance with the requirements of Section 7 B. (1) of these regulations. b. Temperature sensitive autoclave tape, autoclave bags with a chemical color indicator on the bag or any other temperature sensitive medium approved for autoclaves by the Department must be applied to each load each time the autoclave is used. To further confirm that the autoclave is operated in a manner to assure sterility of the processed items, it must also be tested monthly by using a biological indicator such as spore strips or spore suspensions which are processed by a laboratory. Records documenting such testing must be maintained by the operator for three years. A copy of the manufacturer s recommended procedures for the operation of the autoclave is to be available for inspection by the Department. (3) Storage Sterile instruments must be stored in a condition so as to

19 17 maintain their sterility. All sterile and ready to use needles and instruments in their autoclaved bag or container, or in the manufacturer's original packaging shall be kept in an easily cleanable, dry enclosed glass, plastic or metal case, cabinet or drawer while not in use. Such enclosure shall be maintained in a sanitary manner at all times. Sterile instruments may not be used if the package has been breached or after the expiration date without first repackaging and resterilizing. (4) Handling During the body piercing operation, the needles, instruments and supplies shall be used, handled, and temporarily placed as to avoid contamination. B. INSPECTION, SHAVING AND PREPARATION OF THE SKIN (1) No body piercing shall be done on skin surfaces which have any rash, pimples, boils, infections or any other evidence of an unhealthy condition. (2) If the skin is to be shaved, the skin surface must first be washed with soap and warm water. Safety razors with single service blades for each client shall be used for preparation of the areas to be pierced. The blade shall be discarded after each use and the blade holder, if reused, shall be autoclaved after each use. (3) Prior to piercing, the area to be pierced shall be gently scrubbed with individual packets of povidone-iodine or a sterile gauze pad soaked in a germicidal preparation registered with the Environmental Protection Agency and applied in accordance with the manufacturer s recommendations. (4) Only medical grade markers or ink and sterile tooth picks are to be used to identify the areas to be pierced. Gentian violet may be utilized for marking oral piercings. (5) The use of styptic pencils, alum blocks or other solid styptic to check the flow of blood is prohibited. C. BODY PIERCING PROCEDURES (1) The body piercing operator will direct the customer to assure that appropriate jewelry material, sizes and styles for the piercing are selected. Jewelry is to be made from one of the following grades: 316LVM and/or surgical implant grade stainless steel ASTM F138; solid yellow or white gold which is

20 18 14K, or 18K; titanium meeting ASTM Ti6A4V ELI, F136; niobium; platinum; high-density, low porosity non-toxic plastics meeting FDA standards where applicable (Tygon and PTFE); and autoclavable borosilicate glass (Pyrex). Certification of the quality of the jewelry is to be obtained from the manufacturer/supplier and made available for inspection. Substandard jewelry such as that which is damaged, scratched, intended for earlobes or not expressly designed for body piercing, jewelry made of silver, gold plated or filled or other corrosive metal or threaded jewelry sixteen (16) gauge or thicker with external threads shall not be used. Jewelry which has not been sterilized by the manufacturer and maintained in an individual factory sealed package or container is to be placed in a sealed package, dated and sterilized by autoclave. When stored in a closed clean, dry container, jewelry stored in paper autoclave bags may be stored up to three months and up to one year when a full plastic autoclave bag is used. (2) Ear piercing guns may not be used for piercing any part of the body other than ear lobes and the upper ear perimeter. (3) Piercing needles shall be single service and not reused. (4) Individuals other than the certified body piercing operator(s)/apprentice are prohibited from conducting body piercing/insertions in the establishment. D. LINENS If reusable cloth items are used in the care and treatment of the customer, they shall be changed after each use. The used linens shall be placed in an closed or covered container and laundered on a weekly basis or more frequently depending upon storage capacity and degree of contamination of the linen. Used linens shall be laundered either by a regular commercial laundering or by a noncommercial laundering process which includes immersion in laundry detergent and either chlorine bleach water or water at 160 degrees Fahrenheit for not less than 15 minutes during the washing and rinsing operation. The laundered linens shall be stored in a clean, enclosed storage area until needed for immediate use.

21 8. NOTIFICATIONS; CLIENT RECORDS; PROHIBITIONS 19 A. NOTIFICATIONS (1) Verbal and written instructions for the care of the tattoo/pierced site shall be provided to each customer by the operator prior to the initiation of the procedure. The after care instructions for body piercing shall be appropriate for the area being pierced. The written instructions shall advise the customer to consult a physician at the first sign of infection and contain the name, address and phone number of the establishment. The after care instructions shall be made available to the Department upon request. (2) If the body art operator has reasonable cause to suspect that body art is being performed in Philadelphia by an unlicensed operator(s), they shall refer the incident to the Philadelphia Department of Public Health and provide any reasonable assistance or information. B. CLIENT RECORDS (1) Prior to the tattooing or body piercing procedure, the operator is to advise the client to contact a physician prior to the procedure if they fall within any of the following risk categories (suggested informational wording is provided in brackets): (a) History of skin disease or skin cancer at the site of service. [If you currently or in the past have had skin disease or cancer at, around, or near the site, undergoing this procedure will greatly increase the chances of recurrence or magnification of these problems]; (b) History of allergies or anaphylactic reaction to pigments, dyes or other sensitivities. [If you have any known allergies or anaphylactic reaction to any cleaning solutions, dyes, pigments or any other chemical used in the process, please let the technician know so that other preparations can be made.]; (c) Taking medications such as anticoagulants which interfere with the clotting of blood. [If you are currently or have recently taken medications that interfere with normal blood clotting, it is best to consult with your

22 20 physician before obtaining this procedure. Inform the technician of this potential problem] (d) History of hemophilia or other bleeding disorders. [If you have a history of hemophilia, you must consult with a physician regarding the procedure. Some piercings carry an inherent risk of heavy short term bleeding and you must not undergo these procedures without a physician s approval.] (e) Diabetes, peripheral nerve disease, or any deficiency of the immune system [If you have diabetes, there may be a problem with healing in certain areas of the body such as the foot.] (f) Keloid: Existence, propensity or history of keloid formation [Piercing through tissue can be difficult and more painful and can result in the formation of more scar tissue.] (g) Any deficiency of the immune or circulatory system (2) Each operator shall keep records of all tattoos/piercings administered and include the following: customer s name; date; time; identification of tattoo/piercing; and operator's name. Such records shall be retained for a minimum of two (2) years and made available to the Department upon request. C. PROHIBITIONS (1) It is prohibited to perform tattooing or body piercing on any body part of a person under the age of sixteen (16) except when prescribed by a physician s statement. (2) Tattooing or performing body piercing on any body part of a person under the age of eighteen (18) is not to be performed without the written consent of the parent or legal guardian of such minor. This consent is to be given in person to the tattooing artist, body piercer or responsible person at the facility by the parent or legal guardian at the time the tattooing or piercing is to commence. The operator is required to see photographic identification of the adult as well as confirm that the adult is the parent or legal guardian of the minor. (3) It is prohibited to perform tattooing or body piercing on a person who, in the opinion of the operator, is inebriated or

23 21 appears to be under the influence of alcohol or drugs which alter cognitive function. 9. TEMPORARY TATTOO AND BODY PIERCING ESTABLISHMENTS A. GENERAL REQUIREMENTS Temporary tattooing or body piercing operations are to comply with all aspects of the provisions relating to temporary certificates, health, cleanliness and personal hygiene of operators, practices and procedures for tattoo/body piercing establishments and notifications as specified in sections 2, 3, 5, 6, 7 and 8 of this regulation. B. SITE REQUIREMENTS (1) Tattooing/body piercing must be conducted within a building or structure which provides protection against the elements and dust, and is free of insects, rodents, other nuisances or pests. The tattooing/body piercing area is to be separated by a partition from any retail sales or other such activity which may cause potential contamination of work surfaces. (2) Adequate light and ventilation is to be provided at the work location. (3) Facilities shall have easy access to adequate toilet facilities and a lavatory with hot and cold running water, as part of surrounding premises or adjacent to the facility. (4) All needles or any other sharp objects which may have come into contact with blood or blood products are to be disinfected by immersion in a chlorine bleach solution (1 tablespoon of bleach in one quart of water) or autoclaved prior to placement in a sealed rigid container for disposal by the tattoo artist/body piercer. All other wastes are to be removed and properly disposed. 10. EXEMPTIONS A. Medical practitioners licensed by the Commonwealth of Pennsylvania who utilize tattooing or body piercing procedures as part of patient treatment are exempt from these regulations. B. Individuals who pierce only ear lobes or the upper ear leading edge

24 11. SEVERABILITY 22 and strike perimeter are exempt from these regulations when it is demonstrated that equipment, supplies or jewelry that come into contact with the client's ear are sterile, and that the operator s hands that come into contact with equipment, jewelry or the client's skin surface are clean and disposable medical examination type gloves are used. Individuals who use ear piercing guns must conform to the manufacturer's directions on use and applicable U. S. Food and Drug Administration requirements. If any provision or application of any provision of this regulation is held invalid, that invalidity shall not affect other provisions or applications of this regulation. 12. ADMINISTRATIVE COMPLIANCE PROVISIONS NOTE: THE BELOW REQUIREMENTS EXIST IN THE HEALTH CODE AND ARE PROVIDED FOR YOUR INFORMATION CODE OF GENERAL ORDINANCES OF THE CITY OF PHILADELPHIA TITLE 6 - HEALTH CODE * * * Regulation 6-103(3) - Penalties When the Department finds that a public nuisance exists, as provided in 6-402(9)(a) and when such nuisance is not corrected and removed by the person responsible therefor, the Department may, in addition to invoking any other

25 23 sanction or remedial procedure provided: (a) Certify the continuing existence of such nuisance to the Department of Licenses and Inspections which shall itself or by contract abate and remove such nuisance; charge the cost of such abatement and removal to the person responsible therefor; and with the approval of the Law Department, collect such cost by lien or otherwise as may be authorized by law. (b) Apply through the Law Department, to any Court of Common Pleas of Philadelphia for relief by injunction or restraining order against any person responsible for such nuisance, or against any person who knowingly participates in the creation and maintenance of such nuisance by another person. Pursuant to Section 6-402(9)(a) of the Code of General Ordinances of the City of Philadelphia, the following regulations are promulgated by the Board of Health * * * Regulation Business, Professional and Community Controls Regulation 6-402(9) - Nuisances (a) When the Department finds that any continuing violation of the Health Code, the regulations thereunder, or any other continuing health hazard, so injuriously or adversely affects the health of the residents of the City or any portion thereof as to constitute a public nuisance, it may order any person who causes or contributes to the creation and maintenance thereof to correct and remove such nuisance at his own expense. * * * Regulation Orders (1) Except as otherwise provided and subject to the provisions of the Charter, whenever the Department determines that the Health Code or the regulations adopted under it require any action or forbearance from any action to be effected by order, it shall make an order requiring such action or forbearance. (2) All such orders shall be in writing and shall be served on the person from whom action, forbearance, or compliance is required except that

26 24 where the Department finds willfulness or a menace to public health requiring immediate corrective action such orders may be oral in the first instance. (3) Any person to whom such an order is directed or from whom any action, forbearance, or compliance is in any way required shall comply with such order within such period of time as the Department may therein prescribe. (4) While an appeal from an order, as hereafter provided, is pending, compliance with such an order shall not be required unless the Department finds, and certifies in writing such an order, that immediate compliance is necessary to protect the public health. (5) Any person who is aggrieved by an order directed to him or requiring any action, forbearance, or compliance from him may, prior to taking an appeal therefrom pursuant to Section 6-504, request and receive a prompt hearing before the Health Commissioner or any representative specifically designated by him, provided that such request for hearing is made in writing within five days from the receipt of such order. P:\HOME\COMMON\ENV_ENGI\DOC\TATBOD983.TTR